An observational study in Spondylodiscitis, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord, most often with a bacterial etiology. Instrumental diagnosis relies on CT, however, contrast-enhanced MRI is the most sensitive test for confirming the diagnosis, as abnormalities are usually detected earlier than with CT. More recently, nuclear diagnostics using 18-fluorodeoxyglucose (18-FDG) PET has proven very useful both for diagnosis and as a tool for monitoring therapeutic efficacy. Etiological diagnosis relies primarily on blood cultures and, if the former is not possible, diagnostic biopsy. Approximately one-third of patients lack a microbiological isolation, and the inability to implement targeted therapy is a known risk factor for treatment failure.
Therapeutic indications are giving way to shorter courses based on the use of oral medications, even though the epidemiology of the countries from which most of the clinical indications and literature originate is profoundly different from that of Italy. An epidemiological analysis of the cases referred to our Center is therefore of primary importance.
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord. The etiology is most often bacterial, with the main pathogens implicated being Staphylococcus aureus, streptococci, enterobacteriaceae, and other Gram-negative bacilli. Instrumental diagnosis relies on CT, which allows for the detection of lesions such as bony sequestrations and soft tissue abscesses, as well as the exclusion of epidural abscesses. Contrast-enhanced MRI, however, is the most sensitive test for confirming the diagnosis, as abnormalities are usually detected earlier than with CT.
More recently, nuclear imaging, particularly 18-fluorodeoxyglucose (18-FDG) PET, has proven very useful both for diagnosing tissue with high glucose metabolism and as a tool for monitoring therapeutic efficacy. 18F-FDG-PET/CT has been associated with greater accuracy than MRI in diagnosing early spondylodiscitis in the first 2 weeks after symptom onset. Another important advantage of 18F-FDG-PET/CT over MRI is the potential identification of metastatic infectious foci, especially in patients with bacteremia, allowing for rapid source control. 18F-FDG-PET/CT is also useful for spondylodiscitis caused by mycobacteria, fungi, or Brucella, with some data suggesting different uptake values depending on the etiology.
Etiological diagnosis, however, relies primarily on blood cultures, which can be positive in up to 50% of cases of native spondylodiscitis caused by S. aureus. When noninvasive isolation is not possible, a diagnostic biopsy is necessary. Despite the use of invasive techniques, approximately one-third of patients lack microbiological isolation, and the inability to implement targeted therapy is a known risk factor for treatment failure. It also leads to the use of broad-spectrum antimicrobials, with environmental and sometimes economic consequences.
Therapeutic indications, until now based on case series and cohort studies dating back more than 40 years, are giving way to shorter courses based on the use of orally administered drugs. However, the epidemiology of the countries from which most of the clinical indications and literature on bone infections originate is profoundly different from that of Italy. Therefore, an epidemiological analysis of the cases referred to our Center is of primary importance.
24 studies on the registry are indexed under Discitis; 5 are open to participants now.
This study's enrollment of 137 is above the median of 104 across 16 observational studies indexed under Discitis.
Browse Discitis studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
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Patient will be taken from adult male or female population aged ≥ 18 years, who received diagnosis of spondylodiscitis confirmed radiologically and microbiologically and who was admitted to Infectious Diseases Unit between January 1, 2017 and December 31, 2024.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients admitted to the Infectious Diseases Department of the University Hospital of Alessandria between January 1, 2017, and December 31, 2024, who were diagnosed with spondylodiscitis
Descriptive analysis
Description of the characteristics of patients diagnosed with spondylodiscitis admitted to the University Hospital of Alessandria from 2017 to 2024
Time frame: Baseline
Pre- and post-pandemic comparison of clinical and management characteristics of patients with spondylodiscitis
Comparison of the differences in the characteristics of patients hospitalized before and after 06/03/2020 (pre-pandemic and post-pandemic period)
Time frame: Baseline
Comparison of the differences between patients with confirmed and unconfirmed microbiological diagnosis
Evaluate any differences in duration between patients with a confirmed and unconfirmed microbiological diagnosis of spondylodiscitis
Time frame: Baseline
Concordance between PET results and antibiotic therapy
Evaluate the concordance between PET results and antibiotic therapy discontinuation in the absence of relapse at 6 months
Time frame: Baseline
Ran from Jul 2022 to primary completion in Dec 2024, 29 months.
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This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria